Seattle Genetics Receives Orphan Drug Designation for SGN-40 in Multiple Myeloma
Tuesday August 24, 9:00 am ET
BOTHELL, Wash.--(BUSINESS WIRE)--Aug. 24, 2004--Seattle Genetics, Inc. (Nasdaq:SGEN - News) announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to its product candidate SGN-40 for multiple myeloma. SGN-40 is a humanized monoclonal antibody that Seattle Genetics is currently evaluating in a phase I clinical trial for the treatment of multiple myeloma. The company plans to initiate another phase I study of SGN-40 for the treatment of non-Hodgkin's lymphoma later this year.
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"We are advancing our phase I clinical trial of SGN-40 in multiple myeloma and plan to report preliminary data at the American Society of Hematology annual meeting in December," commented Clay B. Siegall, Ph.D., president and chief executive officer of Seattle Genetics. "This orphan drug designation is an important component of our SGN-40 development strategy and provides us with a number of potential financial and marketing benefits."
The Orphan Drug Act is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. Orphan drug designation, granted by the FDA's Office of Orphan Products Development, provides Seattle Genetics with the opportunity to obtain grant funding from the U.S. government to defray costs of clinical trial expenses, tax credits for clinical research expenses, potential waiver of the FDA's application user fee and seven years of marketing exclusivity in the event of market approval. Seattle Genetics previously received orphan drug designations for its SGN-30 product candidate in both Hodgkin's disease and T-cell lymphomas.
About Multiple Myeloma
Myeloma is a cancer of plasma cells, a type of white blood cell found primarily in the bone marrow. In myeloma, a plasma cell becomes malignant, growing continuously, destroying normal bone tissue and crowding out normal blood cell production. Multiple myeloma is an incurable disease in which patients can experience symptoms that significantly impact their quality of life, including pain, anemia, fatigue, recurrent infection and kidney failure. The American Cancer Society estimates that approximately 15,000 new cases of multiple myeloma will be diagnosed in the United States during 2004 and more than 11,000 people will die of the disease.
About Seattle Genetics
Seattle Genetics discovers and develops monoclonal antibody-based therapeutics to treat cancer and other human diseases. The company has built a diverse portfolio of product candidates targeted to many types of cancer, including three being tested in multiple ongoing clinical trials, SGN-30, SGN-15 and SGN-40, and three in preclinical development, SGN-35, SGN-75 and SGN-17/19. The product candidates encompass three platform technologies: genetically engineered monoclonal antibodies, antibody-drug conjugates (ADCs) and antibody-directed enzyme prodrug therapy (ADEPT). Seattle Genetics has developed leading ADC technology comprised of highly potent synthetic drugs and stable linkers for attaching the drugs to monoclonal antibodies. The company currently has license agreements for its ADC technology with Genentech, Celltech Group, Protein Design Labs and CuraGen and for its ADEPT technology with Genencor International. More information about Seattle Genetics can be found at www.seattlegenetics.com. |
